The regulatory challenges in engineering a safer tipple

by Wayne Hall School of Population Health, University of Queensland, Herston, Queensland, 4006, Australia.

David Nutt asks two very important questions. Can we make alcohol safer? Can we use pharmacology and neuroscience to engineer a safer alternative to alcohol?

The answer to the first question is clearly ‘yes’. We can make alcohol safer by encouraging drinkers to consume less alcohol per occasion. That goal can be accomplished by imposing lower taxes on lower alcohol beverages or a volumetric tax on alcoholic beverages (Babor et al., 2003).

On the second question, David Nutt persuasively argues that it will soon be technically possible to develop a gamma-aminobutyric acid (GABA) partial agonist that possesses most of the socially desirable properties of alcohol with few of its disadvantages, including its biological toxicity. The major obstacles to any such product being introduced are social, ideological and regulatory. This is true for any of the ways in which such a drug may be introduced into developed societies; namely, by being approved for use as a therapeutic drug, or being manufactured and distributed by freelance psychopharmacologists.

Challenges to therapeutic registration

There are major doubts about whether the pharmaceutical industry will invest the substantial funds needed to (1) undertake preclinical and clinical R & D on such a drug, and (2) to sponsor the drug’s passage through the pharmaceutical regulatory systems, such as the US Food and Drug Administration or its British and European equivalents. Attempts have been made to introduce alcohol-like drugs in the recent past. Thalidomide, for example, was marketed in Britain by Distillers, an alcohol beverage manufacturer, because its directors thought that it might be an ‘ideal tranquillising agent to replace alcohol among those people who would prefer to “transform their minds” by this alternative means’ (quoted in Insight Team of the Sunday Times, 1979, p. 43).

The recent Foresight Brain Science, Addiction and Drugs project’s survey of pharmaceutical executives (Ragan, 2005) suggests that the industry is now more risk averse. This has been partly in response to critics who have accused the industry of ‘selling sickness’ to promote drugs such as hormone replacement therapy (HRT), Viagra and the selective serotonin reuptake inhibitor (SSRI) antidepressants (e.g. Healy, 2004; Moynihan and Cassels, 2005).

The regulatory system is also likely to discourage any attempt to introduce such a drug as a harm reduction intervention in alcohol dependent patients. Experience with substitute prescribing for nicotine dependence reveals a perverse regulatory double standard that insists upon much tighter regulations for less harmful nicotine products than are imposed on the far more dangerous smoked tobacco products (Stratton et al., 2001). These regulations provide major disincentives to pharmaceutical harm reduction approaches. The prevailing regulatory philosophy seems to be that patients are better off dead than drug dependent even if this means being dependent on a much less hazardous drug or a much less harmful way of using it.

Obstacles to nonmedical use

A safer tipple may emerge as a unintended by-product of basic pharmacological research or it may be approved for therapeutic use for an unrelated indication in which case its desirable properties may be discovered by amateur psychopharmacologists. If the drug proves relatively easy to produce using widely available precursors, then recipes disseminated via the Internet may be used for home production, as has happened with gamma-hydroxybutyric acid (GHB) (Gahlinger, 2004).

Our experience with GHB suggests that if this were to happen the first regulatory impulse would be to ban the drug by making it a criminal offence to produce, sell or use it. This outcome would accord with the conservative regulatory climate in the USA and other developed countries which has ensured that no new recreational substance has been approved for unregulated use in well over a century. During the twentieth century, the recreational use of drugs with psychoactive effects that resemble alcohol (cannabis, MDMA, benzodiazepines and GHB) has prompted their prohibition by classifying them as controlled substances under international drug control treaties (McAllister, 2000).

These major social and regulatory challenges do not invalidate the merit of searching for a safer tipple. This is an idea well worth discussing but we need to do so with our eyes wide open to the major regulatory challenges that historical experience indicates will face any candidate drugs that are developed. A wider public discussion of the possibility is also well worth while, even if only for its educational value in reminding citizens in developed countries that alcohol, their favourite recreational drug, affects brain chemistry in the same way as many prohibited drugs, is an extremely toxic substance when used to excess, as it so often is, and is a major cause of violence, injury and mayhem, especially among young adults.